Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

• ClinicalTrials.gov Identifier: NCT01522092
• Recruitment Status: Withdrawn
• First Posted: January 31, 2012
• Last Update Posted: March 29, 2017
• Sponsor: Hull University Teaching Hospitals NHS Trust
• Information provided by (Responsible Party): Prof A H Morice, Hull University Teaching Hospitals NHS Trust

Tracking Information

• First Submitted Date: January 27, 2012
• First Posted Date: January 31, 2012
• Last Update Posted Date: March 29, 2017
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: January 30, 2012)

exacerbation rate [ Time Frame: 12 months ]

comparison of the rate of COPD exacerbation in the year preceding treatment with that on escitalopram treatment in patients with COPD adjudged to have a significant element of anxiety.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 16, 2014)

• Quality of life [ Time Frame: 12 months ]
  To assess the effect of escitalopram on the patient's quality of life, as measured by St Georges Respiratory Questionnaire
• Hospital Anxiety and depression scale (HADS) [ Time Frame: 12 months ]
  Change in HADS score at 3, 9, and 12 months from baseline
• General anxiety disorder(GAD-7) [ Time Frame: 12 months ]
  Change in GAD-7 score at 3,9 and 12 months from baseline
• Modified Medical Research Council (MMRC) dyspnoea scale [ Time Frame: 12 month ]
  Change in Modified Medical research council Dyspnoea scale at 3, 9 and 12 months from baseline
• BODE index [ Time Frame: 12 months ]
  Change in BODE index at 3, 9 and 12months from baseline
• Health related utilisation [ Time Frame: 12 months ]
  Number of health related utilisations from baseline to 3, 9 and 12 months
• Spirometry [ Time Frame: 12 months ]
  Change in Forced expired volume in 1 sec, Forced vital capacity and Peak expiratory flow measured at 3, 9 and 12 months from baseline

Original Secondary Outcome Measures (submitted: January 30, 2012)

• Quality of life [ Time Frame: 12 months ]
  To assess the effect of escitalopram on the patient's quality of life, as measured by St Georges Respiratory Questionnaire
• Hospital Anxiety and depression scale (HADS) [ Time Frame: 12 months ]
  Change in HADS score at 3, 9, and 12 months from baseline
• General anxiety disorder(GAD-7) [ Time Frame: 12 months ]
  Change in GAD-7 score at 3,9 and 12 months from baseline
• Modified Medical Research Council (MMRC) dyspnoea scale [ Time Frame: 12 month ]
  Change in Modified Medical research council Dyspnoea scale at 3, 9 and 12 months from baseline
• BODE index [ Time Frame: 12 months ]
  Change in BODE index at 3, 9 and 12months from baseline
• Health related utilisation [ Time Frame: 12 months ]
  Number of health related utilisations from baseline to 3, 9 and 12 months
• Spirometry [ Time Frame: 12 months ]
  Change in FEV1, FVC and PEF measured at 3, 9 and 12 months from baseline

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
• Official Title: The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD

Brief Summary

Anxiety and depression are common in patients with severe chronic obstructive pulmonary disease (COPD). Frequently exacerbation's of breathlessness are associated with panic/fear and indeed this may be the main cause for the for hospital admission. Patients prone to a tendency to experience and communicate somatic distress in response to psychosocial stress and to seek medical help for it are top of the "frequent flyer" league, costing the health care economy dearly. This is a particular problem in Hull with the high levels of smoking and urban deprivation combining to place the city at the bottom of the Department of Health COPD league tables.

Our hypothesis is that an effective treatment for anxiety will reduce the number of episodes of hospital admission by reducing the panic/fear element of mild COPD exacerbation's thus allowing the patient time to access the existing community based support services.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Anxiety
• COPD

Intervention

Drug: escitalopram

5mg-20mg, tablet, od, 12 months

Other Name: Cipralex

Study Arms

Experimental: escitalopram

escitalipram tablets 5mg, 10 mg and 20 mg, once a day for 12 months

Intervention: Drug: escitalopram

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: February 19, 2016): 0
• Original Estimated Enrollment (submitted: January 30, 2012): 30
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Male/females aged between 40-80 years.
• Previous diagnosis of COPD confirmed by the GOLD criteria.
• At least two previous admissions to hospital for acute exacerbation of COPD.
• Physician diagnosed anxiety
• At least Mild anxiety score on HADS and GAD-7
• On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion
• Known history of cigarette smoking at least 10 pack yrs
• Willing and able to comply with study procedures
• Able to provide written informed consent to participate

Exclusion Criteria:

• Current or past diagnosis of asthma
• Long-term oxygen therapy
• Currently on treatment with anti-depressives
• Serious inter-current illness (eg lung cancer)
• One year survival considered unlikely
• Patients who have evidence of alcohol or drug abuse
• Participation in another clinical trial with an investigational drug in four weeks preceding the screening visit
• Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus
• Known or suspected hypersensitivity to escitalopram

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01522092
• Other Study ID Numbers: Escit160710; 2010-022038-10 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Prof A H Morice, Hull University Teaching Hospitals NHS Trust
• Study Sponsor: Hull University Teaching Hospitals NHS Trust
• Collaborators: Not Provided

Investigators

• Principal Investigator: Alyn H Morice, Professor; Hull University Teaching Hospitals NHS Trust

• PRS Account: Hull University Teaching Hospitals NHS Trust
• Verification Date: March 2017